Hercules G51796Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00827002517967), received between Apr 26, 2016 and Sep 24, 2026 — classified as 57 malfunctions.

The most frequently reported specific device problem is “Crack” (18 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Off-Label Use

  During a tracheal stenosis dilation procedure, the physician used a Cook HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. It was reported "[that]" a balloon leak was observed in the catheter, requiring a replacement during the procedure.A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883444 ↗
• MalfunctionAug 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50372355 ↗
• MalfunctionAug 10, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194917 ↗
• MalfunctionAug 6, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50163626 ↗
• MalfunctionAug 5, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50144421 ↗
• MalfunctionJul 14, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812647 ↗
• MalfunctionMay 1, 2026Fluid/Blood Leak

  DURING AN ESOPHAGEAL ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] THE BALLOON BURST INSIDE THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058008 ↗
• MalfunctionApr 24, 2026Fracture

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] IT WAS DISCOVERED THAT THE BALLOON SHEATH WAS BROKEN AND HAD NOT ENTERED THE PATIENT'S BODY. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987257 ↗
• MalfunctionMar 2, 2026Fracture

  DURING A NEOPLASTIC STENOSIS OF THE MID-ESOPHAGUS, THE PHYSICIAN USED A HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] THE BALLOON ADVANCED THROUGH A 7 CM NEOPLASTIC MID-ESOPHAGEAL STENOSIS, POSITIONED DISTALLY, AND INFLATED TO 13.5 MM, WHERE IT REMAINED FOR 2 MINUTES. IT WAS THEN DEFLATED AND PULLED TO DILATE THE REMAINING 2 CM. THE CATHETER BROKE DURING TRACTION, THE ENTIRE DEVICE WAS REMOVED, AND A COMPETITOR DEVICE WAS USED TO COMPLETE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24485275 ↗
• MalfunctionJan 29, 2026Material Rupture

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] THE DOCTOR WENT TO PERFORM A FLUSH BEFORE STARTING THE PROCEDURE AND SAW THAT THE BALLOON WAS PUNCTURED. THE CUSTOMER PROVIDED A VIDEO THAT SHOWS THE DEVICE ADVANCED THROUGH THE ENDOSCOPE BUT OUTSIDE THE PATIENT. A SIGNIFICANT AMOUNT OF WATER CAN BE SEEN LEAKING FROM THE BALLOON DURING INFLATION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24212275 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  DURING AN ENDOSCOPIC DILATION PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT THE BALLOON WOULD NOT HOLD PRESSURE BEYOND 30PSI (12MM). WHEN THE BALLOON WAS REMOVED FROM THE PATIENT AND SCOPE, THE BALLOON HAD RUPTURED [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161816 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  DURING AN ENDOSCOPIC DILATION PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT THE BALLOON HAD RUPTURED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161739 ↗
• MalfunctionNov 19, 2025Use of Device Problem; Use of Device Problem

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT THE BALLOON CATHETER BROKE WHEN INTRODUCED. WATER WAS LEAKING AT THE PROXIMAL END OF THE BALLOON THE MOMENT THEY INSUFFLATED WATER. IMAGE OF BROKEN CATHETER WAS PROVIDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597025 ↗
• MalfunctionAug 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ENDOSCOPIC PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] AFTER DILATING [BALLOON] TO 12 [ATM], THE BALLOON POPPED AND WOULD NOT DILATE ANY FURTHER. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905109 ↗
• MalfunctionAug 8, 2025Fracture; Fracture

  DURING AN ENDOSCOPIC DILATATION AND UPPER DIGESTIVE ENDOSCOPY, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] THE DEVICE HAD A PUNCTURED CATHETER. CUSTOMER PROVIDED PHOTO AND VIDEO DEPICTING A CRACK/BREAK IN THE BLUE CATHETER, CONFIRMING THE COMPLAINT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751396 ↗
• MalfunctionJun 17, 2025Fracture; Fracture

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] IT WAS FOUND THAT THE BALLOON CATHETER WAS PUNCTURED. CUSTOMER PROVIDED VIDEO OF PUNCTURED CATHETER LEAKING WATER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235230 ↗
• MalfunctionMay 12, 2025Off-Label Use; Off-Label Use

  DURING A SPHINCTEROPLASTY PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] WHILE PULLING BACK THE BALLOON AFTER SPHINCTEROPLASTY, BALLOON WAS NOT COMING BACK INTO THE SCOPE AND SHEATH PEELED OFF [INTERPRETED TO MEAN BREAKAGE]. CUSTOMER PROVIDED PICTURE OF BROKEN BLUE CATHETER EXPOSING THE INNER PURPLE CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005449 ↗
• MalfunctionApr 25, 2025Fracture; Fracture

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] THE USER ADVANCED THE DEVICE THROUGH WIRE GUIDE TO STENOSIS AREA AND INFLATED THE BALLOON THEN RETRACTED, WHILE FOUND OUT THE BALLOON CANNOT BE RETRACTED INTO ENDOSCOPE WORKING CHANNEL. USER RETRACTED BALLOON ALONG WITH ENDOSCOPE TOGETHER FROM PATIENT'S ESOPHAGUS. THEN USER PULLED THE BALLOON BUT THE BALLOON CANNOT BE RETRACTED INTO ENDOSCOPE WORKING CHANNEL. USER HAD TO CUT OFF THE BALLOON THEN CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. DEVICE WAS EVALUATED ON 01APR2025. DURING EVALUATION IT WAS NOTED THAT THERE IS A HOLE IN THE BLUE TUBING AT 99CM FROM THE HANDLE [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909744 ↗
• MalfunctionFeb 19, 2025Fracture; Fracture

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT DURING THE PROCEDURE WHENEVER [THE PHYSICIAN] TRIED TO INSERT A BALLOON THROUGH A STRICTURE, THE BALLOON CATHETER GOT BROKEN, THE PHYSICIAN USED ANOTHER BALLOON TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415944 ↗
• MalfunctionFeb 19, 2025Fracture; Fracture

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT DURING THE PROCEDURE WHENEVER TRIED TO INSERT A BALLOON THROUGH A STRICTURE BALLOON CATHETER GOT BROKEN DUE TO THIS PROCEDURE NOT BEING COMPLETED, THE PHYSICIAN POSTPONED THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415560 ↗
• MalfunctionDec 6, 2019Fracture; Fracture

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE BALLOON WAS BENT AT THE GUIDEWIRE, AND IT WOULD NOT PASS THROUGH. THIS EVENT WAS NOT REPORTABLE AT THE TIME. ON 13-NOV-2019, THE DEVICE WAS RETURNED AND THERE WAS A BREAK IN THE BLUE CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9432659 ↗
• MalfunctionDec 5, 2019Crack; Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Crack; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

  IN PREPARATION FOR AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN CHOSE A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE USER DETECTED WIRE GUIDE LUMEN WAS LEAKING AT PREPARATION STAGE. THERE WAS NO USE ON THE PATIENT. THE USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. THE VIDEO PROVIDED DEPICTS LEAKAGE FROM THE CATHETER. THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9415512 ↗
• MalfunctionNov 1, 2019Crack; Crack

  PRIOR TO AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN OPENED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE HERCULES BALLOONS HAD A CRACK IN THE MIDDLE OF THE CANNULA THERE WAS A 1/4 INCH GAP. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9268383 ↗
• MalfunctionAug 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIRE GUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. TODAY WE HAD A COOK DILATION BALLOON THAT WOULD NOT INFLATE DURING THE PROCEDURE, AND IN REMOVING IT FROM THE PATIENT AND THEN TRYING TO FILL THE BALLOON, WATER WAS COMING OUT THE END, AND NOT INFLATING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8918124 ↗
• MalfunctionJul 8, 2019Burst Container or Vessel; Off-Label Use; Improper or Incorrect Procedure or Method; Burst Container or Vessel; Off-Label Use; Improper or Incorrect Procedure or Method

  DURING A SPHINCTEROPLASTY [ABNORMAL USE], THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE PHYSICIAN DECIDED TO DO A SPHINCTEROPLASTY IN ORDER TO STRETCH THE AMPULLA TO ALLOW REMOVAL OF A LARGE GALLSTONE. THE FIRST BALLOON USED FOR THIS POPPED AS SOON AS INFLATION WAS ATTEMPTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8767874 ↗